MAUDE Adverse Event Report: COOK INC CHAIT PERCUTANEOUS CECOSTOMY CATHETER; KNT TUBES, GASTROINTESTINAL

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fistula (1862); Discomfort (2330); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

It was reported that an unknown chait percutaneous cecostomy catheter leaked around the insertion site.During a flush with the device, clear fluid leaked from the patient's incision, below the malone site.It was noted that the device flushed well; however, the patient experienced "discomfort".Mild, stable redness was also observed around the incision.The patient then reported to the hospital and was admitted.A fistula between the malone tract and the patient's skin within the subcutaneous fat was discovered.On (b)(6) 2018, the patient's chait was replaced in the operating room.No other adverse effects were reported for this incident.

Manufacturer Narrative

D2a: common device name: additional names: exd irrigator, ostomy.D2b: procode: additional product codes: exd.This report includes information known at this time.A follow-up report will be submitted should additional, relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation a representative from (b)(6) medical center (cincinnati, usa) reported that on an unknown date a chat percutaneous cecostomy catheter (rpn: unknown; lot#: unknown) leaked.After the device was placed, the patient was performing her flush when clear fluid leakage was noted from the incision site below the malone.It was noted that the device was able to flush well; however, the patient experienced discomfort.At the time of leakage, mild, stable redness was observed around the incision site.The patient was then admitted to the hospital and a fistula between the malone tract and subcutaneous skin was diagnosed.As a result, the patient required an additional procedure in the operating room to replace the device.No other adverse effects were reported due to this occurrence.Reviews of documentation including the complaint history, quality control procedures, and instructions for use (ifu) of the complaint device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide the lot number for the complaint device.Cook reviewed the sales history for this customer and was unable to identify the complaint lot.The device history record could not be reviewed.Based on this information, cook has concluded that the device was manufactured to specification and that there is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The ifu pamphlet, t_tdcs_rev7, packaged with the device contains the following in relation to the reported failure mode: contraindications: previous abdominal surgical procedures.Precautions: instruct patient to read and understand the patient guide titled ¿caring for your temporary & chat trapdoor cecostomy catheters¿ prior to initial catheter introduction.Instructions for use: 3.) insert metal stiffener into catheter to straighten coils, and push catheter through tract over pre-positioned wire guide.(fig.2) once catheter is inserted, remove wire guide and metal stiffener until trapdoor is flush against the access site.(when stiffener and wire guide are removed, the extra coils will reform in the cecum.) 4.) perform contrast injection to confirm catheter position and patency within cecum.Patient instructions for maintenance of chat trapdoor cecostomy catheter: note: instruct patient that once chat trapdoor cecostomy catheter is placed, he/she can resume the cecostomy enema regimen previously being used with the temporary cecostomy catheter.The patient should begin antegrade cecostomy enemas on the day following discharge.These enemas should be performed while seated o a toilet.2.) instruct patient to administer a phosphate enema through the connecting tube attached to the chat trapdoor cecostomy catheter.3.) fifteen minutes after initiating infusion of the phosphate enema, patient should attach a saline enema via a gravity bag to complete the enema.4.) patient should continue saline antegrade enema until bowel drainage becomes clear.(usual saline volume is 200-500 ml.) 5.) after use, patient should remove connecting tube and pin from trapdoor fitting, and close fitting to prevent leakage.Based on the information provided, no product returned, and the results of the investigation, the cause for this event could not be established.It is possible that the device was not being maintained properly.It is possible patient interaction with the device could have led to this event.It is possible that the patients pre-existing conditions could have led to this event.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: CHAIT PERCUTANEOUS CECOSTOMY CATHETER
• Type of Device: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 16788945
• MDR Text Key: 313757609
• Report Number: 1820334-2023-00483
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 12 KG